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临床试验/CTRI/2024/02/062922
CTRI/2024/02/062922尚未招募2/3 期

Comparative Study of Analgesic Efficacy of Preoperative Bilateral Superficial Cervical Plexus Block with that of Simple Wound Infiltration with Bupivacaine Dexamethasone Mixture for Thyroidectomies - A Prospective Blinded Study

Dr Aditya Kheny1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年2月26日最近更新:

试验速览

阶段
2/3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
To compare the analgesic efficacy of superficial cervical plexus block with that of local wound infiltration.

研究概览

简要总结

Pain after thyroid surgeries is considered to be of moderate intensity and short duration.

Patient may experience sore throat, odynophagia, burning sensation in the throat, nausea and vomiting which may be cause by the surgical procedure or due to endotracheal tube.

Usually, multimodal analgesia is tried for post operative patients. Non-steroidal anti-inflammatory drugs (NSAIDs) may not be effective for postoperative pain and opioids cause post operative nausea and vomiting.

So, recent studies concerning post thyroidectomy analgesia are focused on the efficacy of regional techniques.

Local anaesthetic wound infiltration (LWI), bilateral superficial cervical plexus block (BSCPB) and bilateral combined superficial and deep cervical plexus blocks are tried with variable results. All these methods share the same principal of cervical plexus sensory blockade at different levels.

LWI is a simple method of post operative pain management, because of its simplicity, safety and low cost. Its efficacy in decreasing post operative pain and analgesic consumption is demonstrated in many procedures like cholecystectomy, hysterectomy and hernia repair.

BSCPB is a popular regional anaesthesia used in thyroidectomy because of its feasibility and efficacy. Use of ultrasound guidance (US) facilitates the procedure by real-time visualisation of anatomical structures and needle movements and increases the chances of successful blockade while decreasing the rate of complications.

So, in this study, we are planning to compare the effectiveness of US guided BSCPB with that of LWI using bupivacaine dexamethasone mixture for post operative analgesia following thyroidectomies. In our study an effort has been made to compare analgesic efficacy and duration of analgesia of superficial cervical plexus block with that of local wound infiltration.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • ASA I to III patients posted for thyroidectomies
  • Aged between 20 to 60 years.

排除标准

  • Patient refusal
  • Patients with history or allergy to local anaesthetics
  • Mentally retarded patients
  • Local infection at the site of procedure
  • Patients with history of chronic analgesic use
  • Patients with huge thyroid swellings
  • Patients with malignant thyroid swellings.

结局指标

主要结局

To compare the analgesic efficacy of superficial cervical plexus block with that of local wound infiltration.

时间窗: Vitals will recorded every 5 mins for the first 20 mins and then every 30 mins till the end of the surgery. Postoperatively, pain assessment will be done using Visual Analog Scale (VAS) at 1 hour after | extubation, 2nd hour, 3rd hour, 6th hour, 12th hour, 24th hour.

To compare the duration of action of superficial cervical plexus block with that of local wound infiltration.

时间窗: Vitals will recorded every 5 mins for the first 20 mins and then every 30 mins till the end of the surgery. Postoperatively, pain assessment will be done using Visual Analog Scale (VAS) at 1 hour after | extubation, 2nd hour, 3rd hour, 6th hour, 12th hour, 24th hour.

次要结局

  • To observe for any postoperative complications.

研究者

发起方
Dr Aditya Kheny
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ashwini H

Rajarajeshwari Medical College and Hospital

研究点 (1)

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